Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients (VIH-2)

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ClinicalTrials.gov Identifier: NCT01605890

Recruitment Status
:
Completed

First Posted
: May 25, 2012

Last Update Posted
: July 12, 2016

Sponsor:

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Collaborators:

Gilead Sciences

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

The HIV-2 is less common ie 1-2 million people in West Africa. HIV-2 does have the same sensibility to antiretroviral treatment (ART) compared to HIV-1. The ART strategies that are appropriate for the HIV-1 infection are not as effective for HIV-2. Classical triple therapy including PI is less effective for HIV-2. Also, the choice of ARTs in a second line treatment is limited. The first line optimal treatment has to be defined by a prospective and randomized evaluation of other strategies. The primary endpoint will be adapted to the specificity of the HIV-2 infection. The 1st step is to define, with a phase II clinical trial, whether a strategy including 2 NRTIs and raltegravir, as an alternative strategy to the classical triple therapy, shows an immunovirological response, at least, as good as the one obtained with the triple therapy. The hypothesis is that the low ART response observed in HIV-2 infection is due to a low virological strength of the ARTs used and that the combination of 2 NRTIs and raltegravir should show a therapeutic success of at least 50% at week 48.

Description of the resistance mutations'profile in virological failure cases [ Time Frame: from Week 0 to Week 48 ]

Description of the resistance mutations'profile in virological failure cases (plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks) with:

the number and type of mutations in the RT and integrase genes compared to Week 0.

the evolution of the phenotypic sensitivity of raltegravir and NRTIs compared to Week 0

Frequency of treatment switch or discontinuation [ Time Frame: from Week 0 to Week 48 ]

overall (regardless of the molecule).

for each study drug (raltegravir and emtricitabine/tenofovir disoproxil fumarate combination).

Evolution of plasma HIV-2 DNA load in PBMC [ Time Frame: at Week 24 and Week 48 and compared to those performed at Week 0 ]

Evolution of the quality of life [ Time Frame: from Week 0 to Week 48 ]

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

age ≥18 years

HIV-2 mono infection, confirmed by ELISA and Western Blot test or Immunoblot,

antiretroviral treatment-naive, whatever the duration and indication of prior treatments,

indication to treatment, with at least one of the following criteria : type B or C events, CD4 lymphocytes count below 500/mm3 at screening-visit or CD4 lymphocytes count decrease of at least 50 cell/µL/year over the last 3 years with the last CD4 lymphocytes count within -/+ 10 % of the nadir, plasma HIV-2 RNA load over or equal to 100 copies/mL at screening-visit,

Pneumocystis prophylaxis if CD4 lymphocytes count below 200/mm3, combined to a toxoplasmosis prophylaxis in case of a positive toxoplasmosis serology,

French residency for at least one year,

Written informed consent, signed by the participant and the investigator (at the latest on the screening-visit and prior any study related intervention)

Affiliate or beneficiary of a social security system (State Medical Assistance is not a social security scheme).

Exclusion Criteria:

Absence of effective contraception method(women),

Pregnancy, breastfeeding or wish for pregnancy during the trial,

Curative treatment of a progressive opportunistic infection not compatible with those evaluated in the present study,